Force transducting inflatable implant system including a dual force annular transduction implant

ABSTRACT

An implant system for restoring and improving physiological intracardiac vortical flow in a human heart is provided including a dual force transducting annular implant comprising laterally extending struts transitioning into annular structural members for positioning on the atrial side of the valve annulus; an anchoring system comprising a therapeutic base plate assembly attachable to the apex of the heart; and a tether assembly comprising a tether connected between the implant and the therapeutic base plate assembly.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of priority under 35 USC § 120 toU.S. patent application Ser. No. 16/021,985, filed Jun. 28, 2018, whichclaims the benefit under 35 USC § 119(e) of U.S. Provisional ApplicationSer. No. 62/526,216, filed Jun. 28, 2017, each of which is herebyincorporated by reference in its entirety.

TECHNICAL FIELD

The present disclosure relates generally to a force transducting,structurally stabilizing, vortex orienting or steering, and functionallyventricular assisting inflatable implant within a human heart forrestoring and improving physiologic vortical intracardiac flow andutilizing the re-purposed native energy and force of theatrioventricular pressure gradient, via force transduction, to restoregeometric elliptical shape, healthy proportion, and proper function tothe atria, the ventricles and ventricular walls, and the valvularapparatus itself.

SUMMARY

An implant system for restoring and improving physiological vorticalintracardiac flow, reducing or impairing atrioventricular pressuregradient loss or regurgitation, improving or restoring ventricularelliptical geometry and function, and providing ventricular functionaland structural support within an impaired human heart is providedincluding both a dual force transducting annular implant, comprisinglaterally extending struts transitioning into annular structuralcomponents for positioning and buttressing and/or anchoring on theatrial side of the valve annulus, and a vortex flow directing implantcomprising an inflatable ‘member’ or bladder; an anchoring systemcomprising a therapeutic base plate assembly attachable to the heart;and a conduit tether or shaft assembly comprising a shaft connectedbetween the implant and the therapeutic base plate assembly.

In some embodiments, the dual force transducting annular implant isfixed at the inflow side of a shaft in the atrium and anchored to thehearts apex. In some embodiments, the dual force transducting annularstructural components on the inflow side are in contact with the annularstructure. In some embodiments, the dual force transducting annularstructural components stabilize the device, center the device, andmechanically connect the valve plane with the apex of the heart and thustransduct or move an increased reparative force to the annulus, thestructures of the heart, the ventricles, and the ventricular walls, andaid in the geometric re-shaping of the impacted ventricle, the reverseor positive remodeling of the ventricles, the reparative strengtheningof the ventricular walls, and assist the ventricle in systolicventricular ejection thus functioning as a passive ventricular assist.By adding a constant amount of cinching force and supporting structurebetween the valve plane and the apex by tethering or anchoring theannulus to the apex of the heart, this becomes a passive ejection assistto aid ventricular ejection and cardiac function. In some embodiments,the annular structural components are fixed in location, in contactwith, and attached to the annular structure, and/or shape and/orre-shape the valve annulus. In some embodiments, the laterally extendingstruts are nitinol or elastic and/or spring-based to absorb, collect,and store, energy and force in one cardiac cycle and then release,discharge, and transfer this energy and force during the subsequentcycle into the endocardium, myocardium, and epicardium via an attachedapical base plate. In some embodiments, the laterally extending strutsare elastic, nitinol, spring-like, and/or another expandable materialdesigned to absorb energy and force in diastole, return energy and forcein systole, and “launch” native cardiac energy and force.

In some embodiments, the dual force transducting annular implant has oneor more contact points in the heart. In some embodiments, the annularstructural components are positioned on the inflow side of the valve. Insome embodiments, the annular structural members are nitinol, elastic,expandable, and/or rigid. In some embodiments, the annular structuralmembers have a covering to promote endothelization.

In some embodiments, the system may further include a vortex flowdirecting implant that further employs the concept of force transductionand vortical flow direction. Force transduction is defined as theintentional movement and re-purposing of native energy and force fromone area of the heart to another area of the heart. The movement of thisenergy and force can be delivered as a restoring therapy to componentsof the heart that have been adversely effected by pathology or cardiacinsult. The design and shape of the vortex flow directing implant alsoenables vectoring and/or directional change of inflowing blood therebyenabling the restoration and enhancement of ventricular vortexformation. Ventricular vortex formation is critical to healthyphysiologic intracardiac blood flow and overall human circulatoryhealth. By placing the vortex flow directing implant atrioventricular,the ‘member’ captures the forces applied by the valve leaflets andvalvulo-ventricular structures driven by the atrioventricular pressuregradient. The atrioventricular pressure gradient is the source of theenergy and force which is captured by the ‘member’ and transferred viathe tether or shaft, and delivered to the ventricles, its structures,and the ventricular free walls via the ball jointed apical base plateand/or a fixed base plate. This delivery of re-purposed energy and forcecreates a restoring, reshaping, and repairing ventricular therapy byre-creating, replicating, and delivering the natural valvulo-ventricularinteraction the native heart has lost due to pathology, cardiac event orinsult, or structural failure. In some embodiments, the dual forcetransducting annular implant is detachable from the vortex flowdirecting implant. In some embodiments, the annular structuralcomponents control the shape of the atrium around the valve annulus. Insome embodiments, the annular structural components may control theshape of the native annulus of the heart.

In some embodiments, the dual force transducting annular implantstructural component defines a “D”-shape and/or saddle shape and/orcircular and/or oval shape. In some embodiments, the vortex flowdirecting implant, acting as a force transducting implant itself byallowing the atrioventricular pressure gradient to act on the exposedsurface area of the implant thereby capturing and/or harnessing itsenergy and force, is fluid-expanding and/or self-forming. In someembodiments, both the dual force transducting annular implant and thevortex flow directing implant, both acting as force transductingimplants, and when attached to a shaft and tethered to an apical baseplate then function or act as an additional or prosthetic ‘papillarymuscle’ transducting and/or moving atrioventricular pressure gradientenergy & force to the ventricular walls, structures, and into theventricle itself.

BRIEF DESCRIPTION OF THE DRAWINGS

The objects, features and advantages of the devices, systems, andmethods described herein will be apparent from the following descriptionof particular embodiments thereof, as illustrated in the accompanyingdrawings. The drawings are not necessarily to scale, emphasis insteadbeing placed upon illustrating the principles of the devices, systems,and methods described herein.

FIG. 1 is a diagram illustrating the vortex flow pattern of a healthyhuman heart.

FIG. 2 is a diagram illustrating the dysfunctional vortex flow patternof a human heart with pathology.

FIG. 3 is a diagram illustrating the structures of a human heart.

FIG. 4 is a diagram illustrating the vortex flow pattern of a healthyhuman heart.

FIG. 5 is a side view of an implant system in accordance with anexemplary embodiment of the disclosed subject matter.

FIG. 6 is a perspective view of the implant system of FIG. 5 inaccordance with an exemplary embodiment of the disclosed subject matter.

FIG. 7 is an enlarged side view of a vortex flow directing implant withthe attached dual force transducting annular implant in accordance withan exemplary embodiment of the disclosed subject matter.

FIG. 8 is a partial cutaway view of an implant system in accordance withan exemplary embodiment of the disclosed subject matter, as positionedin the human heart.

FIG. 9 is an enlarged side view of a vortex flow directing implant inaccordance with an exemplary embodiment of the disclosed subject matter.

FIG. 10 is an enlarged perspective view of a control unit in accordancewith an exemplary embodiment of the disclosed subject matter.

FIG. 11 is a perspective view of an implant system in accordance with asecond exemplary embodiment of the disclosed subject matter.

FIG. 12 is a top view of an implant system in accordance with a secondexemplary embodiment of the disclosed subject matter.

FIG. 13 is an enlarged perspective view of a dual force transductingannular implant in accordance with a second exemplary embodiment of thedisclosed subject matter.

FIG. 14 is a partial cutaway view of an implant system in accordancewith a second exemplary embodiment of the disclosed subject matter, aspositioned in the human heart.

FIG. 15 is a cross-sectional view of an adjustment assembly inaccordance with exemplary embodiments of the disclosed subject matter.

FIG. 16 is an enlarged perspective view of the distal portion of thedual force transducting annular implant system of FIG. 5 . in accordancewith an exemplary embodiment of the disclosed subject matter.

FIG. 17 is an enlarged perspective view of the distal portion of thedual force transducting annular implant system of FIG. 16 with theannular ring portion detached, in accordance with an exemplaryembodiment of the disclosed subject matter.

FIG. 18 is a partial cutaway view of an implant system in accordancewith an exemplary embodiment of the disclosed subject matter, aspositioned in the human heart.

FIG. 19 is a partial cutaway view of the implant system of FIG. 18 , aspositioned in the human heart, with the annular ring remaining and theremainder of the implant system removed.

DETAILED DESCRIPTION

One of the features of the healthy human heart function is properphysiological vortical intracardiac flow. During the ventricularsystolic cycle, considerable forces are naturally generated and thisenergy and force is exerted on the closed or sealed atrioventricularvalve. This filling phase occurs naturally and is powered, inside thehuman heart by a pressure gradient called the ‘atrioventricular pressuregradient’. The atrioventricular pressure gradient is defined as apressure difference (or a pressure differential) that produces orgenerates an energy and a force within the chambers of the heart, thisbeing naturally occurring, naturally initiated, and naturally applied.When the pressure in the atrium is greater than the pressure in theventricle, also called the ‘diastolic’ phase or diastole, blood flowsfrom the higher-pressure atrium into the lower pressure ventricle,causing the atrioventricular valve leaflets to open thereby allowingblood to pass. During the ejection or pumping phase, also called the‘systolic’ phase or systole, the pressure in the atrium is exceeded bythe pressure in the ventricle thereby generating a pressure differentialcreating an energy and force which, in turn, pushes up, onto, andagainst the valve leaflets and causes or effects the valve leaflets toclose and seal off the ventricular chamber from the atrial chamber. Theatrioventricular pressure gradient, then, is the sealing energy andforce required to close the valve. The blood is then ejected from andout of the ventricle, leaving the heart through the aortic valve, andout to the human body. The ventricle, contracts toward the end of thediastolic cycle and beginning the systolic cycle. This contractioninitiates the atrioventricular pressure gradient, mentioned above, thatinitiates this pressure, or energy and force, which ‘closes the valveleaflets’, which then seals the ventricular chamber closed. In theremaining systolic cycle, blood, under high pressure, is then ejectedvia muscular force aided by the healthy ventricular vortex (formed inthe diastolic cycle) to complete the hemodynamic cardiac output for thatparticular cycle. This cardiac cycle continues throughout the humanlifecycle. When the valve leaflets seal properly, the atrioventricularpressure gradient forces close the valve leaflets and maintains andprovides a strong ventricular structure to contain and utilize theatrioventricular pressure gradient for hemodynamic ejection andstructural heart health. The papillary muscles, attached to the chordaetendineae, exercise and pull on the ventricle and ventricular walls thusmaintaining the healthy ventricular shape, the healthy ventricular freewall, and healthy ventricular function (this is natural ‘forcetransduction’). These native forces are delivered via the chordaetendinae and papillary muscles into the ventricular wall. This resultingvalvulo-ventricular interaction keeps the ventricular structure healthyand provides the ventricle with structural support to maintain theproper elliptical ventricular geometry and functional shape. Geometricstability and ventricular function is maintained by imparting energy &force into the ventricular walls to maintain the healthy ventricle, tomaintain the structures of the ventricle, to maintain the structures ofthe valve, and provides for dynamic proper hemodynamic ejection. Duringventricular diastole, the ventricular pressure rapidly decreases. Thevalve opens and blood rushes from the atrium into the ventricle throughthe valve orifice. The valve leaflets function as a steering plane or avectoring lever, directing ventricular flow at an angle or vector todevelop and create an initial spin as illustrated in FIG. 1 . Such anglemay be due to the asymmetry of the valve leaflets and/or to thedifferent shapes and sizes of the leaflets. A vortex progressionresults. It is believed that the inflowing blood leaving the leaflets atangle or vector is critical in the formation of ventricular vortex. Theinitial hemodynamic spin then begins, in which the inflowing blood,engaged by the atrioventricular pressure gradient, then engages thatinitial spin such that a vortex is created downstream. As the bloodleaves the leaflets at vector, due to boundary layer conditions, initialspin begins in which the inflowing blood downstream is engaged (by thepressure differential or gradient) such that a vortex is created in thehealthy elliptically shaped ventricle. The resulting high velocityrotational flow, now a reservoir of kinetic energy within the ventricleis believed significant to proper blood flow velocity and volume throughand out of the heart. Poor or altered vector and/or ventriculardysfunction can alter the formation of the ventricular vortex and thusimpact negatively intracardiac flow and output.

FIG. 2 illustrates that under certain conditions, such as dilatedcardiomyopathy (DCM) in which the heart becomes enlarged, the vortex andvortical flow patterns fail to properly form, geometric stability iscompromised, the papillary muscles displace, and the elliptical shape islost and, subsequently, the ventricle is unable to pump bloodefficiently. Such conditions are marked by a low velocity flow,cascading symptoms such as regurgitation and annular distortion, andpoor cardiac output in which the vortices are abnormal or absent andgeometric distortion is present. Structures of the human heart 21 areillustrated in FIGS. 3 and 4 and referenced below.

In accordance with the disclosed subject matter, an implant system 1 isillustrated in FIGS. 5-13 . Implant system 1 may include, e.g., a dualforce transduction annular implant 1 a, with a vortex flow directing‘member’ 12, or a dual force transduction annular implant 1 b, without avortex flow directing ‘member’ 12, that is positioned within the FIG. 3human heart 21 and connects, cinches and ties the annulus 14 of theatrioventricular valve and it's subvalvular apparatus 15 to the apex 16and/or the ventricular wall 17 of the human heart via a conduit tetheror shaft 6 and then with elastic spring-like property or spring-recoilbased connection or strut 3 to aid in ventricular action and function byabsorbing and loading the energy and force of the atrioventricularpressure gradient during one phase, diastole, and subsequently releasingit during the next phase, systole, of the cardiac cycle; absorbing andloading in one phase and releasing in the subsequent phase. Thisnatively generated energy and force, the atrioventricular pressuregradient, is also captured, harnessed, and the transferred by the vortexflow directing ‘member’ 12 via the tether or shaft 6 to the base plate 9and then through that base plate 9 b into the ventricle 17, itsstructures, and the ventricular free wall 19.

The dual force transducting annular implant 1 a, 1 b is designed to loadenergy and force in the diastolic cycle and release the loaded energyand force in the following systolic cycle, effectively becoming aspring/recoil based assisting device for an impaired ventricle. The dualforce transducting annular implant 1 a therapeutically re-directs andre-purposes this cardiac energy and force via a nitinol, elastic, orspring recoil-based strut 3 in addition to the native atrioventricularpressure gradient energy and force and pressure forces of the structuresof the FIG. 3 heart 21, hemodynamic forces, muscular action, muscularforces, the valve 18, valvular and subvalvular structures 15, androtational energy to effect ventricular systolic and/or diastolicfunction, geometric reshaping of the ventricle 19, structural integrityof the ventricular free wall 17, and ventricular systolic function,acting as a ventricular assist, while at the same time functioning as asupport for the annulus 14 and/or functioning as a reshaping band,framework, or structure. The device in its entirety functions,secondarily, as a shoring-up structural support framework for theweakened or impaired human heart.

The implant 1 a, 1 b includes a self-expanding frame 2, fabricated ofnitinol or any self-expanding or memory shape material. FIG. 13 Strut 3(or a plurality of struts) extend away from the central fixation point4, and include deployed ribs 5 on either side. The ribs 5 transition ata transition point 5 a, also serving as a detaching point or an elbow,into a D-Frame or circular shaped, self-expanding, self-forming orshaped, annular ring or support 7. As illustrated in FIGS. 16 and 17 ,annular ring or support 7 is detachable from the ribs 5 at detachingpoint 5 a. As shown in FIG. 18 , the annular ring 7 is positionedadjacent to the annulus 14. As shown in FIG. 19 , the ring 7 may bedetached from the strut 3, and the implant system 1 a, 1 b removed. Theremaining annular ring 7 conforms to an anatomical topography, e.g.,annulus 14. (see, e.g., FIGS. 18,19 .) Situated or placed above, inproximity to, or at the atrial annular ring 14, on the inflow side ofthe valve 18, the implant 1 a, 1 b has a strut 3, or struts, that arefixed at fixation point 4 onto the distal end of a multi lumen forcetransducting fixed tether or shaft 6, transitioning into an inner fixedtether or shaft 6 a and an outer axially moving tether or shaft 6 b. Theouter axially moving tether or shaft 6 b includes an integratedinflatable axially adjusting balloon 6 c, with the whole of the tetheror shaft transitioning at joint 6 d into a multi lumen tube 8 afterexiting the apex 16 of the heart 21, in this embodiment. The tether orshaft 6, in its entirety, is fixed to the apex 16 of the heart 21 by abase plate 9 and may include a ball joint 9 a, to normalize and evenlytransfer force into the ventricular wall 17. The multi-lumen tubing 8 isconnected to a control unit 10 that adjusts the device performance via afluid communicating system when connected, via the connection point 10 ato the multi lumen tube 8. Control unit 10 is further illustrated inFIG. 10 .

Dual Force Transduction Implant 1 a

According to a first embodiment, the dual force transduction annularimplant 1 a has multiple functions. A first function of dual forcetransduction annular implant 1 a is to mechanically re-connect the valve18 and the subvalvular structures 15 with (or to) the ventricular walls17 in this embodiment, by cinching the annulus 14 to the heart's apex16, and to deploy a nitinol, elastic, spring recoil-based, and/orexternally added energy loading strut 3 to aid in ventricular action andfunction, during the cardiac cycle, by absorbing and loading the energyand force of the atrioventricular pressure gradient during one phase,diastole, and subsequently releasing it during the next phase, systole;absorbing and loading in one phase releasing in the subsequent phase. Itadditionally captures, harnesses, and transducts native energy and forcebeing generated by the FIG. 3 human heart 21 as a whole, e.g., itsmuscular force, hemodynamic energy, and rotational energy, on the atrial20 side of the valve 18, and specifically within the valve 18 and totransduct or move this energy and force via the shaft 6 to thetherapeutic base plate 9 to be therapeutically delivered into theventricular structures 15, 17, 19 and ventricular free walls 17.

A second function of the dual force transduction annular implant 1 a isto restore healthy intracardiac vortical blood flow. The vortex flowdirecting implant ‘member’ 12, placed and fixed in the valve orifice,purposed to intercept, steer, direct, vector, re-vector, and channelatrial inflow thereby passing blood onto and over the valve leaflets andinto the ventricle 19. In positioning and fixing the vortex flowdirecting ‘member’ in such a way, the angle or vector at which the bloodmoves onto and off of the valves leaflets may be influenced, altered, orchanged by increasing or decreasing the girth or inflation of the vortexflow directing ‘member’. This ability of the implant 1, 1 a to changethe vector creates a tool for the initiating, enhancing, restoring,and/or assisting of the formation of ventricular vortex undervisualization such as echocardiography. Positioned atrioventricularly,the vortex flow directing FIG. 9 implant 12 intercepts and re-vectorsblood by channeling the atrial flow via and into the flow directing ribs11 with the transition exiting surfaces 11 a being inside the ventricle.The vortex flow directing implant is the primary instrument of forcetransduction as well. The exposed area of the vortex flow directingimplant 12 is acted on by the valve's leaflets capturing, harnessing,and then re-directing the energy and force of the atrioventricularpressure gradient. The valve leaflets 22 supported by the entirevalvulo-ventricular apparatus 15, ‘grab onto and pull’ the vortex flowdirecting implant 12 during systolic cycle, capturing and re-purposingthe energy and force of the atrioventricular pressure gradient, andrelease during the diastolic cycle; this energy and force beingtransducted via the shaft 6, through the base plate 9, and into thestructures 15 of the ventricles 19 and the ventricular free walls 17.Vortex flow directing implant 12 is further illustrated in FIG. 9 .

A further function of support ring 7 of the dual force transductionannular implant 1 a, 1 b is to act as an annular support for the nativevalve annulus 14 as it is deployed near, to, on, or in proximity to thenative valve annulus 14, assisting in reforming or reshaping adysfunctional native valve annulus, to prevent further distortion,valvular regurgitation, and/or maintain a healthy native valve 18 andvalve annulus 14.

Dual force transduction annular implant 1 a may include a vortex flowdirecting implant 12, further illustrated in FIG. 9 , that captures, atthe line of coaptation 13 or at the point the valve leaflets cometogether on the vortex flow directing implant 12, the native force ofthe atrioventricular pressure gradient, the valvular and subvalularstructures 15, and vatrioventricular pressure gradients (e.g., thedifference in the systolic pressure in the ventricle 19 and the atrium20), as the valve leaflets 22 (See, FIG. 4 ), ‘grab onto and pull’ onthe vortex flow directing implant 12 in systole. The valve leaflets 22act on the exposed surface area in contact of the ‘member’ 12 as theleaflets 22 are influenced to close by the pressure differentialgenerated by the atrioventricular pressure gradient during theventricular systole. This action captures the energy and force conveyedby the atrioventricular pressure gradient. This captured energy andforce is then moved or transducted via the shaft 6 to the base plate 9and into the ventricular structures 15, the ventricle 19, and theventricular free wall 17. This process results in the positivere-shaping of the ventricle called reverse remodeling.

The frame 2, its flexible cross-section struts 3, or strutstransitioning into ribs 5 running parallel to the vortex flow directingimplant 12 down to the atrial side 20 of the annular ring 7, at whichpoint they transition, forming a cinching and connecting (connecting theannulus 14 to the apex 16) tether 6, resting on or in the proximity of,and/or buttressing against the atrial side annular ring 14, of thenative or prosthetic valve.

The vortex flow directing implant 12 attached to the dual forcetransduction annular implant ring (See, FIG. 13 ) may be fixed in thevalve 18. The dual force transduction annular implant 1 a is distallyfixed to the vortex flow directing implant 12 at the top of the shaft 6.The flexible structure 2 and annular ring 7 is cinched up against,buttressed to, and/or fixed to the annulus 14. During systole, the ‘graband pull’ of the valve leaflets 22, the atrioventricular pressuregradient, and the muscular action, motion, energy, and contortion of theendocardium, myocardium, and epicardium are captured by the vortex flowdirecting implant 12 (by allowing the pressure differential to act onthe exposed area of the ‘member’ 12) while the dual force transductionannular implant 1 a releases its loaded energy and force. The elastic,spring recoil-based, and/or external energy is loaded, added, and thentransferred together by the dual force transduction annular implant 1 aas it presses on the annulus 14, it is now cinched, connected, andtethered to the apex, by the shaft 6 to the base plate 9, to the apex 16of the heart 21. This, now, compounded energy and force, loading indiastole and releasing in systole, is delivered via the shaft 6 to thebase plate 9 and therapeutically transferred into the structures 15, theventricles 19, and the ventricular walls 17 thus restoring, assisting,or re-creating the valvulo-ventricular interaction a healthy ventricleexperiences and requires.

The flow channel creating rib(s) 11 running at angle 11 a along thesurface of the vortex flow directing implant 12 directs or re-directsthe intercepted flow of blood onto and off of the valve leaflets 22, andfacilitates establishment a proper vector upon entry into the ventricle19 under visualization as the vector can be altered by increasing ordecreasing the ‘member’ 12 width or girth. This hemodynamic re-vectorenhances, assists, restores (the missing), and/or enables the naturalphysiologic vector, thereby facilitating and/or enhancing therestoration of the ventricular vortex, critical to physiologic healthyintracardiac flow. The valvular and subvalvular structures 15, 22‘grabbing and pulling’ of the vortex flow directing implant 12 (allowingthe pressure differential to act on the exposed area of the ‘member’ 12)along with the additional elastic, spring-recoil based, and/orexternally added force delivered by the dual force transduction annularimplant 1 a, in effect becomes a prosthetic, or an additional, papillarymuscle 23 to assist the native papillary muscles 23, replaces lostvalvulo-ventricular interaction, which enables, repairs, and supportsventricular health, ventricular contraction, ventricular ejection, andassists in maintaining a healthy ventricular structure and ventricularwall structure, by transducting this captured native energy and forcevia the base plate 9 which then, by tether 6 to and contact with theapex 16 and ventricle 19, and utilizing specific edge shapes 9 b,delivers this captured and harnessed natural energy and force into theventricular walls 17, thereby aiding in systolic function and inducingreverse remodeling (positive geometric reshaping) of that structure 19,21.

Dual Force Transduction Annular Implant 1 b

According to a second embodiment, the dual force transduction annularimplant 1 b has several functions. The dual force transduction annularimplant 1 b is substantially identical to dual force transductionimplant 1 a, with the differences noted herein. In particular, dualforce transduction annular implant 1 b does not include the vortex flowdirecting implant 12. The flexible or rigid cross sectional structure 3,strut, and/or struts, transitioning into ribs 5, the ribs 5 thentransitioning into a D-Frame or circular shaped, self expanding annularring 7 conforming to an anatomical topography 14, and cinching orconnecting (mechanically connecting the annulus 14 to the apex 16) to anitinol, elastic, spring recoil-based, and/or externally added energy tothe annulus 14 and/or ventricular wall 17 to aid or assist inventricular function, during the cardiac cycle, by absorbing and loadingenergy during one phase, and subsequently releasing it during the nextphase, absorbing and loading in one phase releasing in next phase. Thatenergy and force is captured and loaded by distal implant andtransferred via the tether or shaft 6 from the valve annulus 14 to theapex 16. This energy and force is the transducted muscular action,muscular force, and rotational energy and force of the heart, deliveredby the shaft 6, to the base plate 9, which then therapeutically deliversthis energy and force into the ventricular structures 15, 19 andventricular walls 17.

This cinching and connecting (connecting the annulus 14 to the apex 16)tether or conduit 6 from the atrial 20 side of the annulus 14 to theapex 16 of the heart 21 creates an additional method or delivery ofnative energy and force capture by tethering between the annulus andapex thus assisting the native papillary muscles 23, deliveringadditional cardiac muscular energy, compounded, into the ventricularwalls 17 and structures via the shaft 6, and the ‘ball jointed’ 9 a baseplate 9 during systole and diastole. The dual force transduction annularimplant 1 b, its structure 2,7, and ribs 5 running out and away from thefixation point 4 at the top of the shaft 4, 6, down to the atrial 20side of the annular ring 2, at which point they transition forming asupporting ring 2, 7 resting and buttressing the attached device 2,distal to the annular ring 14, in such a manner, that during systole,the muscular motion, energy, and contortion of the endocardium,myocardium, and epicardium is captured and loaded in one phase,delivered or released in another, and this energy and force deliveredvia the shaft 6 to the ‘ball jointed’ 9 a base plate 9 andtherapeutically transferred 9, 9 b into the ventricle 19, theventricular structures and ventricular walls 17.

Another function of ring 7 of dual force transduction annular implant 1b is to act as an annular support ring for the valve annulus 14 as it isdeployed near, to, on, or in proximity to the valve annulus 14 assistingin reforming or re-shaping a dysfunctional valve annulus 14.

The dual force transduction implant 1 b may be fixed to an axially orlongitudinally adjustable shaft 6, which may increase the force bymoving the shaft 6 proximally, thereby increasing the pressure of theconnection 14 between the annular ring 7 and the apex 16 of the heart,or decrease the force by moving the shaft 6 distally thereby decreasingthe pressure of the connection between the annular ring 14 and the apex16 of the heart. The energy and force delivery occurs via the conduit orshaft 6 to the base plate 9, which then transfers the energy and forceinto the ventricular structures 15, 17, 19. In cinching the annulus 14to the apex 16, the energy and force loaded in the diastolic phase andreleased in the systolic phase can be adjusted by moving the tether orshaft 6 distally for less added force or proximally for more addedforce.

The fixed, ‘ball jointed’ 9 a base plate 9, with round oval cutouts 9 cto allow fibrous tissue in-growth for long term security, pulls the apex16 upward in systole and releases the apex 16 in diastole and, inconjunction with the elongated therapeutic extensions 9 b of the base 9plate extending up the sides of the ventricle 9 b, impart by contact,specific shape, and fixation this transducted energy into the ventricle19, inducing a physiologic response by replacing the lostvalvulo-ventricular interaction, which critically supports ventricularcontraction and assists in maintaining a healthy ventricular wallstructure, required to maintain healthy geometric ventricular 19 shape.

The control unit 10, illustrated in FIG. 10 , above, may be used witheither dual force transduction implant 1 a or 1 b or the vortex flowdirecting implant 12 and have three or more independent containedchambers 10 b, 10 c, 10 d, each identifiable below the skin by palpableprotrusions, one palpable protrusion for chamber one 10 b, two palpableprotrusions for chamber two 10 c, and three palpable protrusions forchamber three 10 d. A single connection point 10 a places the controlunit 10 in communication, via the connecting multi-lumen tubing 8 andshaft 6, with the vortex flow directing implant 12, and has a needleaccess pad of ePTFE, any semi-porous, or non-porous material, thatallows fibrous tissue in growth (the body's method of preventinginfection and facilitating hemostasis). Additional compartments may beadded to house, store, and/or accommodate additional sensoringequipment, power sources, data transmission equipment, or the sensorsthemselves.

By reference to FIGS. 9 and 10 , in one of chambers 10 b 10 c 10 d, asealed compartment is introduced to house a power source for sensoringnodes implanted within the device 1 a, 1 b itself, the implant system 1then becoming a housing platform for these sensoring nodes. One or morelumens of the connecting multi-lumen connecting tube 8 may be used toconnect the power source with the sensoring nodes. In one of chambers 10b 10 c 10 d, fluid is introduced or removed from the integratedinflatable axial adjusting balloon 6 a to increase or decrease the axialpositioning shaft 6 of the vortex flow directing implant 12 as reversere-modeling occurs. In one of chambers 10 b 10 c 10 d, fluid is added toincrease or decrease the girth of the vortex flow directing implant 12.In one of chambers 10 b 10 c 10 d, fluid is added or removed to createcrescent shaped articulation 12 b in the wings 12 a of vortex flowdirecting implant 12, either anterior or posterior, to better vector theintercept of blood from atrium 12 by introducing fluid into the ‘wing’chambers 12 a via a skeletal crescent beam with lumen (not shown).

With continued reference to the first embodiment, FIG. 15 illustrates anovel piston 25 fixed to the moving portion 6 b of the shaft 6 within acylinder 24 fixed to said shaft 6. The piston 25 may be contained withinthe shaft 6 and/or within the vortex flow directing implant 12 thatallows the sliding shaft 6 a, the vortex flow directing implant 12 andthe cylinder 24, to axially or longitudinally move up (arrow 26) anddown (arrow 27) as the fluid in the vortex flow directing implant 12,powered by the atrioventricular pressure gradient, rises and falls asthe heart naturally cycles through diastole and systole.

During diastole, the fluid contained within the vortex flow directingimplant 12 moves proximally (arrow 27, forced by the pressuredifferential and/or the hemodynamic in flow to the bottom portion of thevortex flow directing implant 12 and then, conversely, rises distally(arrow 26), under pressured force to the distal 26 end of the vortexflow directing implant 12, during systole thereby causing the fluidcontained within the vortex flow directing implant 12 to move with anenergy and force and fill the distal portion of the vortex flowdirecting implant 12. The cylinder 24, via the two side positioned fillholes 28, is then filled by fluid, under pressure and force, and drivesthe piston 25 proximally (arrow 27). This novel cylinder 24 is housedwithin the inflatable vortex flow directing implant 12 and fixed to thedistal end of the vortex flow directing implant 12 by the shaft 6 at thecentral fixation point 4. The piston 25 moves independently within thecylinder 24 and is driven proximally (arrow 27) (a) by fluid filling the‘piston chamber bowl’ 29 under pressure, via the two side positionedcylinder fill holes 28, (b) by the fluid influenced and powered by thenative systolic forces. The piston 25 moves the entire vortex flowdirecting implant 12 distally (arrow 26), thereby creating a new,additional, and/or redirected energy and force, from the fluid'sdistal/proximal exchange (arrow 26/arrow 27), during the heart's cycle.

In an exemplary embodiment, a fluid exchange system is provided bypiston 25, which is operated and/or natively ‘powered’ (by theatrioventricular pressure gradient during the systolic cycle) and is atherapeutic component being driven by the heart's natural energy andforce, generated, captured by vortex flow directing implant 12 andredirected by shaft 6, delivered in a therapeutic manner, during naturaldiastole and systole utilizing the fluid contained and driven within thevortex flow directing implant 12. The movement of the fluid housedwithin the vortex flow directing implant 12, being driven to the distalend 26 of the vortex flow directing implant 12 during the systoliccycle, forces fluid into the cylinder fill holes 28, located on eachside of the cylinder 24, and fills the piston chamber bowl 29 in thesystolic cycle, and pressurizes the chamber (29) (arrow 26), therebymoving the piston contained within the vortex flow directing implant 12distally (arrow 26), in the heart's cycle, generating a re-directedtherapeutic force when transducted and/or delivered to the ventricularstructures 15, 17, 19 and ventricular free walls 17. The cylinder 24,fixed to the implant 4 and the vortex flow directing implant 12, insystole, raises the vortex flow directing implant 12 distally (arrow26), and conversely, in diastole, reverses the action (arrow 27). Thevortex flow directing implant 12 now becomes a ‘pumping piston,’delivering an additional energy and force augmenting thevalvulo-ventricular interaction 15, an in effect becomes an additionalpapillary muscle 23, delivering native energy and force, via the conduitor shaft 6 and via the base plate 9, into the ventricular structure 19and/or the ventricular free walls 17. Conversely, by lowering thecylinder side fill holes 28 to a position 30 below the piston 25, thereverse is achieved, e.g., in diastole the piston 25 is driven distally(arrow 26), the vortex flow directing implant 12 now moves proximally(arrow 27), and in systole the piston 25 is driven proximally (arrow27), the vortex flow directing implant 12 now moving distally (arrow26).

It will be appreciated that the methods and systems described above areset forth by way of example and not of limitation. Numerous variations,additions, omissions, and other modifications will be apparent to one ofordinary skill in the art. Thus, while particular embodiments have beenshown and described, it will be apparent to those skilled in the artthat various changes and modifications in form and details may be madetherein without departing from the spirit and scope of this disclosureand are intended to form a part of the disclosure as defined by thefollowing claims, which are to be interpreted in the broadest senseallowable by law.

What is claimed is:
 1. An implant system for restoring ventriculargeometric shape and changing vortical physiological intracardiac flow(ventricular vortex) in a human heart comprising: a dual forcetransducting annular implant comprising laterally extending strutstransitioning into annular structural components for positioning theimplant and transducting force on the atrial side of a valve annulus; ananchoring system comprising one or more therapeutic base plateassemblies attachable to the heart's apex or wall; a tether assembly,comprising a tether or tethers or shaft, connected between the implantand the one or more therapeutic base plate assemblies; a conduitproviding a fluidic connection; and a control unit.